Gardasil (Human Papillomavirus Quadrivalent Vaccine) is a recombinant vaccine against Human Papillomavirus types 6, 11, 16, and 18. It is recommended for men and women for the prevention of genital and anal cancers caused by HPV.

Gardasil (Human Papillomavirus Quadrivalent Vaccine) Uses:

• Prevention of human papillomavirus infection:

  • Females ≥9 years of age and ≤26 years of age:
    • Prevention of anal cancer caused by HPV types 16 and 18 and anal intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18.
  • Females ≥9 years of age and ≤45 years of age:
    • Prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18;
    • genital warts caused by HPV types 6 and 11;
    • cervical adenocarcinoma in situ, vulvar, vaginal, or cervical intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18.
  • Males ≥9 years of age and ≤26 years of age:
    • Prevention of anal cancer caused by HPV types 16 and 18;
    • anal intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18;
    • genital warts caused by HPV types 6 and 11

The Canadian National Advisory Committee on Immunization (NACI) recommends routine vaccination for females and males between 9 and 26 years of age. It should not be administered in patients <9 years of age but may be administered to patients >26 years of age who are at ongoing risk of exposure.

Read Details about other human papillomavirus vaccines:

• Cervarix (Human Papillomavirus Bivalent Vaccine) - Dose, Schedule
• Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) - Dose, Schedule

Gardasil (Human Papillomavirus Quadrivalent Vaccine) Dose in Adults

Gardasil (Human Papillomavirus Quadrivalent Vaccine) Dose in the Prevention of human papillomavirus infection: IM:

• Adults:

  • Females ≤45 years of age and males ≤26 years of age:
    • Three-dose series: 0.5 mL at 0, 2, and 6 months.
    • Administer the second dose ≥1 month after the first dose and the third dose ≥3 months after the second dose; administer all 3 doses within 12 months.

• NACI recommendations:

  • Recommended for females and males ≤26 years of age; may be given to those ≥27 years of age who are at ongoing risk.

Gardasil (Human Papillomavirus Quadrivalent Vaccine) Dose in Childrens

Gardasil (Human Papillomavirus Quadrivalent Vaccine) Dose in the Primary immunization:

• CDC (ACIP) recommended immunization schedule:

  • In a 2-dose series, the minimum interval between the first and second dose is 5 months.
  • In a 3-dose schedule, the minimum interval between first and second doses is 4 weeks; between second and third dose is 12 weeks, and in-between first and third doses is 5 months.

• Non-immunocompromised patients and certain medical conditions:

  • Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system, anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:
  • Children ≥9 years and Adolescents <15 years:
    • 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months.
    • Administer the first dose at age 11 to 12 years;
    • patients with a history of sexual abuse or assault, start vaccine at 9 years of age.
  • Adolescents ≥15 years:
    • 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

• Immunocompromised Patients:

  • Immunocompromised patients, including those with conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy:
  • Children ≥9 years and Adolescents:
    • 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

Gardasil (Human Papillomavirus Quadrivalent Vaccine) dose for Catch-up immunization: CDC/ACIP recommendations:

Note:

• Do not restart the series.
• If doses have been given, begin the below schedule at the applicable dose number.

• Children ≥9 years and Adolescents:

  • IM: 0.5 mL per dose for a total of 2 to 3 doses (See CDC/ACIP recommendations above for 2-dose vs. 3-dose schedule criteria):
    • The first dose is given on the selected date
    • The second dose is given a minimum of 4 weeks after the first dose (for a 3-dose schedule) or 5 months following the first dose (for a 2-dose schedule).
    • Third dose (for a 3-dose schedule) given a minimum 12 weeks after the second dose and at least 5 months following  the first dose

Gardasil (Human Papillomavirus Quadrivalent Vaccine): B

• It is not advised to give the human papillomavirus vaccination during pregnancy.
• The risk of adverse pregnancy outcomes from exposure to the human papillomavirus vaccine is not known until more information is available.
• The manufacturer suggests that you avoid pregnancy during the vaccine series.

Human papillomavirus quadrivalent vaccine use during breastfeeding:

• It is unknown if the vaccine is found in breast milk.
• If indicated, breastfeeding mothers may be given the human papillomavirus vaccination.
• Breastfeeding is safe when the administration is given to both mother and baby.
• Breastfeeding infants should be vaccinated according to the recommended schedules.

Dose in Kidney Disease:

No dosage adjustments provided in the manufacturer's labeling.

Dose in Liver disease:

No dosage adjustments provided in the manufacturer's labeling.

Common Side Effects of Gardasil (Human Papillomavirus Quadrivalent Vaccine):

• Central nervous system:

  • Headache

• Local:

  • Pain at the injection site
  • Swelling at the injection site
  • Erythema at the injection site

• Miscellaneous:

  • Fever

Less Common Side Effects of Gardasil (Human Papillomavirus Quadrivalent Vaccine):

• Central Nervous System:

  • Dizziness

• Dermatologic:

  • Injection Site Pruritus

• Gastrointestinal:

  • Nausea
  • Diarrhea
  • Toothache
  • Vomiting

• Local:

  • Hematoma At Injection Site

• Neuromuscular & Skeletal:

  • Limb Pain
  • Arthralgia
  • Myalgia

• Respiratory:

  • Oropharyngeal Pain
  • Upper Respiratory Tract Infection

Contraindications to Gardasil (Human Papillomavirus Quadrivalent Vaccine):

Hypersensitivity to any vaccine component or to a prior dose

Warnings and precautions

• Anaphylactoid reactions and hypersensitivity reactions

  • Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use.

• Syncope

  • Syncope can be caused by injectable vaccines. It is most commonly seen in adolescents and young adults and occurs within 15 minutes of vaccination.
  • It is important to have procedures in place to prevent injuries from falls, and to restore cerebral blood flow if necessary.

• Acute illness:

  • The severity of the symptoms and the etiology determine whether or not vaccination should be administered.
  • Patients with severe or moderate acute illness should be delayed (with or with fever); patients with mild acute illness (with fever) should not be vaccinated.

• Bleeding disorders:

  • Patients with bleeding disorders, including thrombocytopenia, should be cautious.
  • Administration of IM may cause bleeding/hematoma.
  • If the patient has received antihemophilic therapy or another similar therapy, IM injections can be scheduled within a few hours.

• Infection with human papillomavirus, HPV

  • It is not clear that HPV-infected individuals will be protected.
  • However, those infected by 1 or more HPV types have been protected from the disease in the other HPV types.
  • For the treatment of active diseases.

Monitoring parameters:

• Screening for HPV is not required prior to vaccination.
• Monitor for anaphylaxis and syncope for 15 minutes after administration.
• If seizure-like activity associated with syncope occurs, keep the patient in supine or Trendelenburg position to maintain adequate cerebral perfusion.
• Females:
  • Gynecologic screening exam, papillomavirus test;
  • screening for cervical cancer should continue per current guidelines following vaccination.

How to administer Gardasil (Human Papillomavirus Quadrivalent Vaccine)?

IM:

• Shake the suspension well before use.
• Do not use if discolored or contains particulate matter, or if the syringe is cracked.
• Inject the entire dose IM into the deltoid region of the upper arm or higher anterolateral thigh area.
• Do not mix with other vaccines or injections; use separate needles and syringes for each injection.
• For patients at risk of hemorrhage following IM injection, administer the IM vaccine only at treating clinicians' discretion.
• If the patient receives antihemophilic or other similar therapy, schedule intramuscular vaccination shortly after such therapy.
• Use fine needle (23 gauge or smaller), apply firm pressure (without rubbing) for at least 2 minutes.
• Educate patients regarding the risk of hematoma at the injection site.
• Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders.

Mechanism of action of Gardasil (Human Papillomavirus Quadrivalent Vaccine):

• It contains inactive human papillomavirus proteins (HPV) HPV 6 L1, 11 L1, 16 L1, and 18 L1 that produce neutralizing antibodies to protect against cervical cancer, cervical adenocarcinoma and genital warts.
• Cross-protective efficacy of the vaccine is not available for HPV types that are not included in the vaccine.
• The prevalence of HPV in the area and the subject characteristics (e.g. lifetime sexual partners) will determine the population's benefit from vaccination.

Efficacy:

• 100% effective against HPV types 16 and 18, related cervical disease, and 95% to 99 percent effective against external genital lesions related to HPV types 6, 11, 16 or 18, in females between 16 and 26 years old.
• Effectiveness: 84% to 100%External genital lesions resulting from HPV types 6, 11, 16 or 18 in males between 16 and 26 years old are not recommended.
• Effectiveness: 91%For HPV 6, 11, 16 and 18 persistent infections and cervical or external Genital Diseases
• Effectiveness: 83%Only against HPV types 16-18 in females between 26 and 45 years old.
• Additionally, HPV 16 and 18 vaccinations may protect against 70% anogenital cancers as well as 60% of high-risk cervical precancerous lesions.

Onset:

• Seroconversion was seen 1 month after the last dose of vaccine

Duration:

• Unknown.
• Clinical studies followed HPV4 vaccinated participants for 10 years and found no evidence of decreasing protection.

International Brands of Human papillomavirus quadrivalent vaccine:

• Gardasil

Human papillomavirus quadrivalent vaccine Brands Names in Pakistan:

• No Brands Available in Pakistan.